ASCO23: Enhertu shows 37.1% response rate in HER2-expressing solid tumoursHER2-expressing solid tumours

05 Jun 2023
firstwordpharma.com
Clinical ResultASCOPhase 2Phase 1ADC
Results from the Phase II DESTINY-PanTumor02 study showed that AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) led to an objective response rate (ORR) of 37.1% in patients with HER2-expressing solid tumoursHER2-expressing solid tumours. The findings for the HER2-directed antibody-drug conjugate were detailed Monday at the American Society of Clinical Oncology (ASCO) annual meeting.
The companies said earlier this year that in the trial, Enhertu met the prespecified target for ORR and demonstrated durable responses. The study enrolled 267 patients with HER2-expressing biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumoursHER2-expressing biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumours, including 75 with IHC 3+ expression and 125 with IHC 2+ expression.
Higher HER2 levels = better response
According to the latest interim results, at a median follow-up of 9.7 months, the median duration of response (mDOR) in the overall study population was 11.8 months, while 49.6% of responders remained in response at one year. In patients with IHC 2+ expression, the ORR was 27.2%, rising to 61.3% in those with IHC 3+ expression. Meanwhile, the mDOR in these two groups was 9.8 months and 22.1 months, respectively.
Lead author Funda Meric-Bernstam said "these results advance our clinical understanding of HER2 expression, reaffirm HER2 as an actionable biomarker across a broad range of tumour types, and show that [Enhertu] could potentially provide a new treatment option for patients with advanced disease across these tumours, especially in patients with HER2 IHC 3+ or 2+ expression."
The highest responses by tumour type in DESTINY-PanTumor02 were seen for endometrial cancer and cervical cancer, where the ORR in those with IHC 3+ expression was 84.6% and 75%, respectively. Results showed that while the majority of patients were able to tolerate Enhertu, with the most common treatment-related side effects being nausea, fatigue and cytopenia, 11.6% of participants stopped treatment due to adverse events (AEs). Grade ≥3 AEs occurred in 58.4% of patients, with drug-related interstitial lung disease/pneumonitis occurring in 7.5% of study subjects, although the majority were low grade.
Commenting on the findings, ASCO expert Bradley Alexander McGregor noted "while additional follow-up is needed, there is robust activity across multiple HER2 expressing tumours with over 50% response rate in those with the highest levels of HER2 expression coupled with an encouraging safety profile."
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